Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center

NCT01016613 | Recruiting DMC

• 1 other identifier: P30DK081943
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 5

Brief Summary

Chronic kidney disease (CKD) affects approximately 26 million Americans and disproportionately manifests in specific race and ethnic groups. Patients burdened with CKD have significant morbidity and reduced life expectancy. In addition to excessive suffering and lost productivity, the cost of managing this epidemic has reached $40 billion annually. The recognition that CKD is a major public health problem is reflected in the fourteen objectives outlined in Healthy People 2020 to begin to address the disease burden. Advancement in approaches to halt CKD progression has been slow despite growing global awareness of disease burden. This O'Brien Kidney Research Core will create opportunities for novel insights through characterization of tissue profiles that will define new disease markers and molecular pathways and will be available to all kidney investigators on the www. It will thereby fundamentally alter the starting point for research into prevention of progression of these kidney diseases. C-PROBE is an essential element of the center grant and presents a biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic identification of observable physical and biomedical characteristics) of kidney disease patients including the accurate measurement of kidney function; and (2) a specimen BioBank which will store blood, urine and kidney tissue samples. A key component of C-PROBE is therefore that it contains a proven mechanism to collect samples from high risk groups including minorities, at the institutions of University of Michigan Health System, St. John Hospital, Wayne State University in Michigan, John H. Stroger Hospital in Illinois, Temple University Health System in Pennsylvania, and Levine Children's Hospital in North Carolina. This mechanism will feed the other Cores and provide biomedical investigators with approved projects the access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research.

Conditions

Chronic Kidney Disease; Glomerulopathy

Keywords

chronic kidney disease; glomerulonephritis; proteinuria; nephrotic syndrome; nephropathy; biobank

Study Arms (3)

Chronic Kidney Disease Cohort

chronic kidney disease patients with any type of kidney disease

Matched Control Group

Healthy controls

Trios

First degree relatives of pediatric chronic kidney disease cohort members

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nephrology clinic patients and community members

You may qualify if:

• persons of any age who have chronic kidney disease (abnormally high protein in urine or reduced kidney function determined by blood tests)
• a small number of people without chronic kidney disease

You may not qualify if:

• people on hemodialysis or peritoneal dialysis
• people who have had a kidney transplant
• people unable or unwilling to provide consent
• women who are pregnant or nursing
• adults who have polycystic kidney disease
• institutionalized persons
• people currently participating in a blinded interventional clinical trial

Sponsors & Collaborators

• University of Michigan: lead
• St. John Health System, Michigan: collaborator
• Temple University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (5)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

Wayne State University

Detroit, Michigan, 48201, United States

COMPLETED

St. John's Health System

Detroit, Michigan, 48236, United States

COMPLETED

Levine Children's Hospital

Charlotte, North Carolina, 28207, United States

COMPLETED

Temple University

Philadelphia, Pennsylvania, 19140, United States

COMPLETED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood and renal tissue, if available

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Glomerulonephritis; Proteinuria; Nephrotic Syndrome; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nephritis; Urination Disorders; Urological Manifestations; Signs and Symptoms; Nephrosis

Study Officials

• Subramanium Pennathur, MBBS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Crystal A Gadegbeku, MD

  The Cleveland Clinic

  STUDY DIRECTOR

• Matthias Kretzler, MD

  University of Michigan

  STUDY DIRECTOR

• Markus Bitzer, MD

  University of Michigan

  STUDY DIRECTOR

Central Study Contacts

Chrysta Lienczewski

CONTACT

734-615-5021; boridley@med.umich.edu

Markus Bitzer, MD

CONTACT

734-763-4688; markusbi@med.umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: January 1, 2009
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)